DOSAGE AND ADMINISTRATION
2.1).
Recommended start dose: 10 or 20 mg once daily (2.1).
Patients requiring large LDL-C reduction (>45%) may start at 40 mg once
daily (2.1).
Pediatric starting dose: 10 mg once daily; maximum recommended dose: 20 mg
once daily (2.2).
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Hyperlipidemia (Heterozygous Familial and Nonfamilial) and Mixed Dyslipidemia (Fredrickson Types IIa and IIb)
The recommended starting dose of LIPITOR is 10 or 20 mg once
daily. Patients who require a large reduction in LDL-C (more than 45%) may be
started at 40 mg once daily. The dosage range of LIPITOR is 10 to 80 mg once
daily. LIPITOR can be administered as a single dose at any time of the day, with
or without food. The starting dose and maintenance doses of LIPITOR should be
individualized according to patient characteristics such as goal of therapy and
response (see current NCEP Guidelines). After
initiation and/or upon titration of LIPITOR, lipid levels should be analyzed
within 2 to 4 weeks and dosage adjusted accordingly.
Heterozygous Familial Hypercholesterolemia in Pediatric Patients (10–17 years of age)
The recommended starting dose of LIPITOR is 10 mg/day; the
maximum recommended dose is 20 mg/day (doses greater than 20 mg have not been
studied in this patient population). Doses should be individualized according to
the recommended goal of therapy [see current NCEP Pediatric
Panel Guidelines,
Clinical
Pharmacology
, and
Indications and Usage
]. Adjustments should be made at intervals
of 4 weeks or more.
Homozygous Familial Hypercholesterolemia
The dosage of LIPITOR in patients with homozygous FH is 10 to 80
mg daily. LIPITOR should be used as an adjunct to other lipid-lowering
treatments (e.g., LDL apheresis) in these patients or if such treatments are
unavailable.
Concomitant Lipid-Lowering Therapy
LIPITOR may be used with bile acid resins. The combination of
HMG-CoA reductase inhibitors (statins) and fibrates should generally be used
with caution [see
Warnings and Precautions,
Skeletal Muscle, Drug Interactions (7)
].
Dosage in Patients With Renal Impairment
Renal disease does not affect the plasma concentrations nor LDL-C
reduction of LIPITOR; thus, dosage adjustment in patients with renal dysfunction
is not necessary [see
Warnings and
Precautions, Skeletal Muscle, Clinical Pharmacology,
Pharmacokinetics
].
Dosage in Patients Taking Cyclosporine, Clarithromycin, Itraconazole, or a Combination of Ritonavir plus Saquinavir or Lopinavir plus Ritonavir
In patients taking cyclosporine, therapy should be limited to
LIPITOR 10 mg once daily. In patients taking clarithromycin, itraconazole, or in
patients with HIV taking a combination of ritonavir plus saquinavir or lopinavir
plus ritonavir, for doses of LIPITOR exceeding 20 mg, appropriate clinical
assessment is recommended to ensure that the lowest dose necessary of LIPITOR is
employed [see
Warnings and Precautions,
Skeletal Muscle, Drug Interactions (7)
].
DOSAGE FORMS AND STRENGTHS
White, elliptical, film-coated tablets containing 10, 20, 40, and 80 mg
atorvastatin calcium.
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